Henry Weiss

Experience

1. Scientific Consultant- Chemistry, Manufacturing & Controls

   Cardinal Health

   Nov 2021 — Present · Miami, FL, US

   Lead global CMC regulatory strategy and execution for complex pharmaceutical development programs, supporting INDs, BLAs, MAAs, and post‑approval lifecycle management across multiple regions.• Direct high‑priority global regulatory submissions, independently defining dossier strategy, overseeing technical authoring, and ensuring timely delivery in alignment with FDA, EMA, and other health authority expectations.• Provide strategic oversight for major filing documentation, ensuring inspection readiness, regulatory compliance, and adherence to evolving ICH, GMP, and global CMC standards.• Develop and implement contamination control, Quality Risk Management (QRM), and Quality by Design (QbD) strategies for GMP manufacturing environments to strengthen quality systems and mitigate regulatory risk.• Mentor and develop junior scientists while collaborating cross‑functionally with Analytical Development, Process Development, Manufacturing, Quality, and Regulatory Affairs to align CMC strategy with program and commercial needs.

Education

• Xavier University

  Bachelor of Science (B.S.), Biology

  2009 — 2012

• TASIS-Switzerland

  International Baccalaureate

  2006 — 2009

• Northwestern University

  Master of Science (M.S.), Biotechnology

  2013 — 2015